Entornos Controlados
GMP Annex 1 · AEMPS · EMA · FDA · Full DQ/IQ/OQ/PQ
GMP environments with the complete Contamination Control Strategy required by the revised Annex 1.
En detalle
Building a pharmaceutical cleanroom is necessary. Passing a regulatory inspection is the real objective. Our GMP environments deliver the complete Contamination Control Strategy (CCS) required by the revised Annex 1 (EU, 2022): pressure cascades, segregated personnel and material flows, validated gowning-room architecture, certifiable surface finishes. ICH Q7 for active substances. ICH Q9 for quality risk management. GMP Annex 15 for qualification and validation. DQ/IQ/OQ/PQ as a standard deliverable.
Regulatory framework covered: Regulation (EU) 2023/1182 and GMP Annex 1, EMA guidelines, FDA 21 CFR Parts 210 and 211. For Spanish-speaking markets: AEMPS (Spain), COFEPRIS (Mexico), ANMAT (Argentina), and INVIMA (Colombia) — all with expedited pathways that recognize EMA and FDA as reference authorizations. One documentation package. Every market.
Grade D to Grade A — every GMP class, every regulatory framework, a single project owner.
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MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass the Notified Body and FDA with the same documentation package.
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Live pathogens. Pharmaceutical GMP. Both in the same facility — resolved by a single engineering team.
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Pharmaceutical-grade purity. Industrial-scale economics. High-potency containment where both are simultaneously required.
See more →Sectores aplicables
Grade D to Grade A — every GMP class, every regulatory framework, a single project owner.
See more →Sectores aplicables
MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass the Notified Body and FDA with the same documentation package.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — resolved by a single engineering team.
See more →Sectores aplicables
Pharmaceutical-grade purity. Industrial-scale economics. High-potency containment where both are simultaneously required.
See more →Sectores aplicables
Grade D to Grade A — every GMP class, every regulatory framework, a single project owner.
See more →Sectores aplicables
MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass the Notified Body and FDA with the same documentation package.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — resolved by a single engineering team.
See more →Sectores aplicables
Pharmaceutical-grade purity. Industrial-scale economics. High-potency containment where both are simultaneously required.
See more →Sectores aplicables
Preservation environments for museums and archives, with stable temperature and humidity plus continuous monitoring.
